New heat treatment could replace surgery for rare pancreatic tumors
NCT ID NCT05735912
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a less invasive procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with standard surgery for treating pancreatic insulinoma, a rare tumor that causes low blood sugar. About 60 adults with small tumors (≤2 cm) will be randomly assigned to one of the two treatments. The goal is to see if EUS-RFA is safer and just as effective as surgery in relieving symptoms and preventing recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency ablation (a procedure using heat to destroy tumor cells)
- What this could lead to
- If successful, this could offer a safer, less invasive alternative to surgery for small pancreatic insulinomas, reducing hospital stays and recovery time.
- What could go wrong
- This is a relatively small trial (60 people) and the procedure may not be as effective as surgery in the long term, with possible tumor recurrence or incomplete symptom relief.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, C-peptide blood levels) * Presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound). * No evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound * Tumor ≤ 2cm * Informed consent provided by the patient or closest relative. Exclusion Criteria: * G2 with Ki-67 \>5% on histological examination at EUS-guided biopsy samples (if performed) * Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct * Metastatic tumor at the time of diagnosis * Multiple pancreatic nodules * Diagnosis of multiple endocrine neoplasia type 1 according to guidelines * Unfit for surgery or high-risk surgical patients * Endoscopic ultrasound not feasible for surgical altered anatomy * Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma * Use of anticoagulants that cannot be discontinued * International normalized ratio \>1.5 or platelet count \<50.000 * Pregnancy or breast feeding * Failure to sign the patient's or closest relative's informed consent
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic insulinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University Hospital of Verona
Verona, 37138, Italy